WO2006111653A1 - Utilisation de l’ agomelatine pour l'obtention de medicaments destines au traitement des troubles bipolaires - Google Patents

Utilisation de l’ agomelatine pour l'obtention de medicaments destines au traitement des troubles bipolaires Download PDF

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Publication number
WO2006111653A1
WO2006111653A1 PCT/FR2006/000859 FR2006000859W WO2006111653A1 WO 2006111653 A1 WO2006111653 A1 WO 2006111653A1 FR 2006000859 W FR2006000859 W FR 2006000859W WO 2006111653 A1 WO2006111653 A1 WO 2006111653A1
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WO
WIPO (PCT)
Prior art keywords
treatment
agomelatine
pharmaceutically acceptable
bipolar
pharmaceutical compositions
Prior art date
Application number
PCT/FR2006/000859
Other languages
English (en)
French (fr)
Inventor
Christian De Bodinat
Elisabeth Mocaer
Original Assignee
Les Laboratoires Servier
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
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Application filed by Les Laboratoires Servier filed Critical Les Laboratoires Servier
Priority to AP2007004212A priority Critical patent/AP2656A/xx
Publication of WO2006111653A1 publication Critical patent/WO2006111653A1/fr
Priority to TNP2007000364A priority patent/TNSN07364A1/en
Priority to IL186373A priority patent/IL186373A/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/22—Anxiolytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system

Definitions

  • the present invention relates to the use of agomelatine or N- [2- (7-methoxy-1-naphthyl) ethyl] acetamide of formula (I):
  • bipolar disorders in particular bipolar disorders of types I and II, and more particularly type I bipolar disorders.
  • Agomelatine or N- [2- (7-methoxy-1-naphthyl) ethyl] acetamide has the dual peculiarity of being on the one hand agonist on the receptors of the melatoninergic system and on the other hand antagonist of the 5-HT receptor 2 c- These properties give it an activity in the central nervous system and more particularly in the treatment of major depression, seasonal depression, sleep disorders, cardiovascular pathologies, pathologies of the digestive system, insomnia and fatigue due to time differences, appetite disorders and obesity.
  • Bipolar disorder is a psychopathological condition that has the most severe impact on the lives of patients, both socially, personally and professionally. They are characterized by the generally repeated occurrence of depressive episodes, manic, hypomanic or mixed separated by periods during which the subjects are a priori free of major psychic dysfunction. In other words, patients suffering from bipolar disorder are marked by a vulnerability to present marked fluctuations in mood recurrently. The characteristics of access and their evolution over time makes it possible to distinguish several clinical forms: bipolar disorder type I is the most typical and is characterized by one or more manic or mixed episodes usually accompanied by major depressive episodes; Type II bipolar disorder concerns the association of at least one major depressive episode and an episode of hypomania, an attenuated form of mania. The risk of suicide of bipolar patients is very high: 25 to 50% of them have made at least one suicide attempt.
  • bipolar disorders There is currently no satisfactory and recognized treatment for bipolar disorder.
  • First-line treatments are usually mood stabilizers or mood stabilizers, but these treatments are often unable to relieve depressive symptoms (J. Clin Psychiatry, 2004, 65 (4), 569-579).
  • the concomitant prescription of an antidepressant although frequently used, is a very controversial practice because they can trigger or aggravate manic and mixed states, and should be stopped at the onset of manic episodes.
  • Antidepressants are particularly known to promote the induction or acceleration of hyperthymal cycles, to promote two to three times more the occurrence of a manic or hypomanic turn, and finally their prolonged use seems to lead to an increase in the number of depressive and manic episodes.
  • agomelatine can be used in the treatment of bipolar disorders, especially bipolar disorders of types I and II, and more particularly in bipolar disorders of type I, alone or in combination.
  • agomelatine in bipolar disorders and more particularly in bipolar I disorders were, by the very fact of its activity in depression, those antidepressants described in the literature as paroxetine, for example.
  • agomelatine does not behave as a classic antidepressant, as has been observed in a clinical study in patients with bipolar I disorder. These results suggest its use. , even prolonged, in bipolar disorders, especially bipolar disorders of types I and II, and more particularly in type I bipolar disorders.
  • the invention thus relates to the use of agomelatine, as well as its hydrates, crystalline forms and addition salts with a pharmaceutically acceptable acid or base, alone or in combination, for obtaining pharmaceutical compositions intended for the treatment bipolar disorders, in particular bipolar disorder type I and II, and more particularly type I bipolar disorder.
  • the invention also relates to the association between agomelatine and a mood stabilizer or thymoregulator for obtaining pharmaceutical compositions intended for the treatment of bipolar disorders, in particular bipolar disorders of types I and II, and more particularly bipolar disorders. of type I.
  • the mood stabilizers or thymoregulator according to the invention relate to lithium, antiepileptics, such as carbamazepine, valproate and lamotrigine. More particularly, the mood stabilizer or thymoregulator of the combination according to the invention will be lithium. or valproate.
  • agomelatine When agomelatine is associated with a mood stabilizer, it may be administered before, during or after the mood stabilizer, provided that the time interval between both administrations achieve the desired synergistic effect on the central nervous system.
  • a pharmaceutical composition containing agomelatine and the mood stabilizing agent, in combination with one or more pharmaceutically acceptable excipients will be preferred.
  • compositions will be presented in forms suitable for oral, parenteral, transcutaneous, nasal, rectal, perlingual administrations, and in particular in the form of injectable preparations, tablets, sublingual tablets, glossettes, capsules, capsules, tablets, suppositories, creams, ointments, dermal gels, etc.
  • compositions according to the invention contain one or more excipients or vehicles chosen from diluents, lubricants, binders, disintegrating agents, absorbents, dyes, sweeteners, etc.
  • lactose lactose, dextrose, sucrose, mannitol, sorbitol, cellulose, glycerin,
  • binders aluminum magnesium silicate, starch, gelatin, tragacanth, methylcellulose, sodium carboxymethylcellulose and polyvinylpyrrolidone,
  • disintegrants agar, alginic acid and its sodium salt, effervescent mixtures.
  • the appropriate dosage varies according to the sex, age and weight of the patient, the route of administration, the nature of the condition and any associated treatments and ranges from 1 mg to 50 mg of agomelatine per 24 hours. .
  • the daily dose of agomelatine will be 25 mg per day.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Epidemiology (AREA)
  • Psychiatry (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Pain & Pain Management (AREA)
  • Hospice & Palliative Care (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Plant Substances (AREA)
PCT/FR2006/000859 2005-04-20 2006-04-19 Utilisation de l’ agomelatine pour l'obtention de medicaments destines au traitement des troubles bipolaires WO2006111653A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
AP2007004212A AP2656A (en) 2005-04-20 2006-04-19 Use of agomelatine in obtaining medicaments intended for the treatment of bipolar disorders
TNP2007000364A TNSN07364A1 (en) 2005-04-20 2007-09-26 Use of agomelatine for obtaining medicaments used for treating bipolar disorders
IL186373A IL186373A (en) 2005-04-20 2007-10-07 Use of agomaltin for medication to treat bipolar disorders

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0503937A FR2884714B1 (fr) 2005-04-20 2005-04-20 Utilisation de l'agomelatine pour l'obtention de medicaments destines au traitement des troubles bipolaires
FR0503937 2005-04-20

Publications (1)

Publication Number Publication Date
WO2006111653A1 true WO2006111653A1 (fr) 2006-10-26

Family

ID=35311309

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/FR2006/000859 WO2006111653A1 (fr) 2005-04-20 2006-04-19 Utilisation de l’ agomelatine pour l'obtention de medicaments destines au traitement des troubles bipolaires

Country Status (41)

Country Link
US (1) US7947743B2 (pt)
EP (1) EP1714647B1 (pt)
JP (2) JP4580364B2 (pt)
KR (2) KR100835451B1 (pt)
CN (2) CN1853619B (pt)
AP (1) AP2656A (pt)
AR (1) AR057277A1 (pt)
AT (1) ATE491443T1 (pt)
AU (1) AU2006201655B2 (pt)
BR (1) BRPI0601285A8 (pt)
CA (1) CA2544136C (pt)
CR (1) CR9426A (pt)
CY (1) CY1111257T1 (pt)
DE (1) DE602006018822D1 (pt)
DK (1) DK1714647T3 (pt)
EA (1) EA013462B1 (pt)
ES (1) ES2357901T3 (pt)
FR (1) FR2884714B1 (pt)
GE (1) GEP20094651B (pt)
GT (1) GT200600141A (pt)
HK (1) HK1093906A1 (pt)
HR (1) HRP20110083T1 (pt)
IL (1) IL186373A (pt)
JO (1) JO2666B1 (pt)
MA (1) MA28266A1 (pt)
ME (1) ME01951B (pt)
MY (1) MY143171A (pt)
NO (1) NO336010B1 (pt)
NZ (1) NZ546630A (pt)
PE (1) PE20061337A1 (pt)
PL (1) PL1714647T3 (pt)
PT (1) PT1714647E (pt)
RS (1) RS51659B (pt)
SG (1) SG126868A1 (pt)
SI (1) SI1714647T1 (pt)
TN (1) TNSN07364A1 (pt)
TW (2) TW200940049A (pt)
UA (1) UA83681C2 (pt)
UY (1) UY29470A1 (pt)
WO (1) WO2006111653A1 (pt)
ZA (1) ZA200603160B (pt)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7608737B2 (en) 2007-05-01 2009-10-27 Concert Pharmaceuticasl Inc. Naphthyl(ethyl)acetamides
MD20120062A3 (ro) * 2011-08-10 2016-06-30 Les Laboratoires Servier Compoziţie farmaceutică solidă de agomelatină pentru administrare bucală

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2890563B1 (fr) * 2005-09-09 2007-10-19 Servier Lab Nouvelle association entre l'agomelatine et un agent thymoregulateur et les compositions pharmaceutiques qui la contiennent
EP2856934A1 (en) * 2013-10-04 2015-04-08 Les Laboratoires Servier Biomarkers for the prediction of long term remission in depression

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005063297A2 (en) * 2003-12-24 2005-07-14 Sepracor Inc. Melatonin combination therapy for improving sleep quality

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2658818B1 (fr) * 1990-02-27 1993-12-31 Adir Cie Nouveaux derives a structure naphtalenique, leur procede de preparation et les compositions pharmaceutiques qui les contiennent.
US5585118A (en) * 1995-06-02 1996-12-17 Brigham And Women's Hospital Choline in the treatment of bipolar disorder
WO2002067924A1 (en) * 2001-02-27 2002-09-06 Ortho-Mcneil Pharmaceutical, Inc. Carbamate compounds for use in preventing or treating bipolar disorder
FR2834890B1 (fr) * 2002-01-23 2004-02-27 Servier Lab Composition pharmaceutique orodispersible d'agomelatine
AR047553A1 (es) * 2003-07-04 2006-01-25 Lundbeck & Co As H La combinacion de un inhibidor de reabsorcion de serotonina y agomelatina

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005063297A2 (en) * 2003-12-24 2005-07-14 Sepracor Inc. Melatonin combination therapy for improving sleep quality

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
CHILMAN-BLAIR K ET AL: "AGOMELATINE. ANTIDEPRESSANT TREATMENT OF BIPOLAR DISORDER MELATONIN AGONUST/5-HT20 ANTAGONIST", DRUGS OF THE FUTURE, BARCELONA, ES, vol. 28, no. 1, January 2003 (2003-01-01), pages 7 - 13, XP009036058, ISSN: 0377-8282 *
GRAUL A I: "ANNUAL UPDATE 2003: DRUGS FOR PSYCHIATRIC DISORDERS AND SUBSTANCE ABUSE", DRUGS OF THE FUTURE, BARCELONA, ES, vol. 28, no. 11, 2003, pages 1103 - 1144, XP008030818, ISSN: 0377-8282 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7608737B2 (en) 2007-05-01 2009-10-27 Concert Pharmaceuticasl Inc. Naphthyl(ethyl)acetamides
MD20120062A3 (ro) * 2011-08-10 2016-06-30 Les Laboratoires Servier Compoziţie farmaceutică solidă de agomelatină pentru administrare bucală

Also Published As

Publication number Publication date
PT1714647E (pt) 2011-01-14
IL186373A (en) 2012-06-28
GT200600141A (es) 2006-11-22
AU2006201655B2 (en) 2009-04-23
GEP20094651B (en) 2009-03-25
HRP20110083T1 (hr) 2011-03-31
TW200716083A (en) 2007-05-01
KR20060110803A (ko) 2006-10-25
AR057277A1 (es) 2007-11-28
ATE491443T1 (de) 2011-01-15
ES2357901T3 (es) 2011-05-03
US7947743B2 (en) 2011-05-24
SG126868A1 (en) 2006-11-29
ME01951B (me) 2011-10-31
EA013462B1 (ru) 2010-04-30
JP2006316056A (ja) 2006-11-24
KR20080028389A (ko) 2008-03-31
TWI318115B (en) 2009-12-11
JP5341037B2 (ja) 2013-11-13
CY1111257T1 (el) 2015-08-05
CN1853619B (zh) 2011-02-02
AU2006201655A1 (en) 2006-11-09
NO336010B1 (no) 2015-04-20
JP2010280699A (ja) 2010-12-16
MA28266A1 (fr) 2006-11-01
BRPI0601285A (pt) 2006-12-19
PE20061337A1 (es) 2007-01-27
SI1714647T1 (sl) 2011-03-31
JO2666B1 (en) 2012-06-17
US20060240127A1 (en) 2006-10-26
IL186373A0 (en) 2008-08-07
EA200600600A1 (ru) 2006-10-27
AP2656A (en) 2013-05-07
EP1714647B1 (fr) 2010-12-15
HK1093906A1 (en) 2007-03-16
UA83681C2 (uk) 2008-08-11
CN102038669A (zh) 2011-05-04
CN1853619A (zh) 2006-11-01
CR9426A (es) 2008-02-21
RS51659B (en) 2011-10-31
ZA200603160B (en) 2007-06-27
KR100835451B1 (ko) 2008-06-09
FR2884714A1 (fr) 2006-10-27
PL1714647T3 (pl) 2011-05-31
NO20061705L (no) 2006-10-23
UY29470A1 (es) 2006-05-31
MY143171A (en) 2011-03-31
NZ546630A (en) 2007-09-28
TW200940049A (en) 2009-10-01
DE602006018822D1 (de) 2011-01-27
JP4580364B2 (ja) 2010-11-10
FR2884714B1 (fr) 2011-05-06
CA2544136A1 (fr) 2006-10-20
TNSN07364A1 (en) 2008-12-31
BRPI0601285A8 (pt) 2021-03-30
DK1714647T3 (da) 2011-03-07
AP2007004212A0 (en) 2007-10-31
CA2544136C (fr) 2012-02-21
EP1714647A1 (fr) 2006-10-25

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